🇺🇸 LUTATHERA in United States

FDA authorised LUTATHERA on 26 January 2018

Marketing authorisations

FDA — authorised 26 January 2018

  • Application: NDA208700
  • Marketing authorisation holder: AAA USA INC
  • Status: supplemented

FDA

  • Status: approved

LUTATHERA in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is LUTATHERA approved in United States?

Yes. FDA authorised it on 26 January 2018; FDA has authorised it.

Who is the marketing authorisation holder for LUTATHERA in United States?

AAA USA INC holds the US marketing authorisation.